In a complaint (PDF) in the U.S. District Court for the Southern District of New York on June 7, Chanthinia White indicates that Bayer Healthcare failed to adequately warn her and other consumers about the PTC/IIH risk, and the importance of monitoring for signs or symptoms of the issue.

White had a Mirena IUD implanted without complications in June 2014, according to the lawsuit. However, in March 2017, she was diagnosed with PTC/IIH, after suffering intense headaches, blurred vision, double vision and dizziness.

PTC/IIH is a serious medical condition, which has been linked to other birth control products. However, Mirena warnings failed to provide any indication that users may experience problems, or that they should seek immediate medication attention if vision issues or headaches develop.

While the fluid pressure around the brain can often be treated, if permanent optic nerve damage is suffered due to PTC/IIH, women may be left with blindness or other long-term complications.

The lawsuit indicates that Bayer knew or should have known that the Mirena could cause PTC/IIH.

“Defendants placed Mirena into the stream of commerce with wanton and reckless disregard for the public safety,” the lawsuit states. “Defendants knew or should have known that Mirena, and specifically, the synthetic progestin levonorgestrel, causes and/or contributes to the development of IIH/PTC, a severe and possibly irreversible brain condition.”

White’s claim joins a growing number of Mirena IUD lawsuits filed in federal courts nationwide, each raising similar allegations that women may have avoided serious injuries if adequate information had been disclosed to consumers and the medical community.

In late April, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings for all cases brought by women diagnosed with PTC/IIH from the Mirena birth control implant, centralizing the claims before U.S. District Judge Paul A. Englemayer in the Southern District of New York.

As part of the coordinated pretrial proceedings, it is expected that Judge Englemayer will establish a bellwether program, where a small group of cases will be prepared for early trial dates to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.